Smart Heart Trial: Structured Lifestyle Intervention for Overweight and Obese Youth With Operated Heart Defects (SHT)

Kambiz Norozi

Status: Completed

Conditions: Pediatric Obesity; Congenital Heart Disease

Treatments: Behavioral: Lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02980393

102392

18843 (Other Identifier)

Details and patient eligibility

About

This study is to assess whether a lifestyle intervention with diet, exercise and counselling in young patients will have a positive influence on their weight and overall well-being. This study will enrol patients between the ages of 7 to 17 years of age, who have congenital heart disease, and have been identified being overweight or obese. A total of 40 individuals will participate in this study. The study duration will last for 1 year.

Enrollment: 40 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• overweight or obese (BMI> 85%) patients
• between 7-17 years of age
• operated or non-operated congenital heart disease
• reside in Southwestern Ontario

Exclusion criteria

• inability to comply with research testing or intervention components due to mental and/or physical disabilities, medications or comorbidities affecting weight or metabolic condition
• involvement in any concurrent lifestyle intervention program

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Lifestyle intervention

Experimental group

Description:

Participants are guided by a fitness specialist who will help the participants to incorporate physical activity into their daily life. Based on the cardiologist assessment, an individual home-based exercise program will be developed. Participants are also guided and advised on nutrition with emphasis on low fat content and increased fiber. The nutrition counseling will focus on sustainable changes and will help participants to make healthy food choices.

Treatment:

Behavioral: Lifestyle intervention